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Randomized trial of three different regimens for 24 weeks for re‐treatment of chronic hepatitis C patients who failed to respond to interferon‐α monotherapy in Taiwan
Author(s) -
Chuang WanLong,
Dai ChiaYen,
Chen ShinnCherng,
Lee LiPo,
Lin ZuYau,
Hsieh MingYuh,
Wang LiangYen,
Yu MingLung,
Chang WenYu
Publication year - 2004
Publication title -
liver international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.873
H-Index - 110
eISSN - 1478-3231
pISSN - 1478-3223
DOI - 10.1111/j.1478-3231.2004.0954.x
Subject(s) - ribavirin , medicine , combination therapy , gastroenterology , alpha interferon , randomized controlled trial , hepatitis c virus , chronic hepatitis , interferon , hepatitis c , immunology , virus
With the favorable result of interferon (IFN)–ribavirin combination therapy for 24 weeks among naive Taiwanese chronic hepatitis C (CHC) patients, the optimal regimens of re‐treatment for CHC patients who failed initial IFN monotherapy is not well‐established. The study evaluated the effectiveness of re‐treatment for 24 weeks with 3 different regimens and predictors for sustained virological response (SVR). Methods: Total 120 Taiwanese CHC patients (81 males, 70 relapsers, mean age: 48.6 years) who failed initial IFN monotherapy were enrolled. They were assigned randomly (with a ratio of 1:1:2) to receive one of the three regimens for re‐treatment for 24 weeks; group A: IFN 6 million units (MU) monotherapy ( N =30), group B: combination therapy with ribavirin and IFN 3 MU ( N =30) or group C: combination therapy with ribavirin and IFN 6 MU ( N =60). The intention‐to‐treat rate of sustained virological response (SVR) was 38.3%. The SVR rate in group C (53.3%) was significantly higher than group A (16.7%, P <0.005) and group B (30%, P <0.05). Drop‐out rates were similar between the three groups. Patients achieving SVR had significant improvement histologically. Hepatitis C virus (HCV) genotype non‐1b infection, lower pretreatment HCV RNA levels, combined with ribavirin and with higher IFN dose, and relapsers were independent predictors for SVR. Conclusion: We concluded that more than one‐third Taiwanese CHC patients achieved SVR after 24 weeks re‐treatment and combination therapy, especially with higher dose of IFN, yielded higher efficacy.